Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000694910
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
7/07/2011
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an exercise training intervention on clinical and functional outcomes for obese individuals following intensive energy restriction
Scientific title
The effects of an exercise training intervention on clinical and functional outcomes for morbidly obese females who have undergone laparoscopic adjustable gastric banding (LAGB) or a very low energy diet
Secondary ID [1] 262485 0
Nil
Universal Trial Number (UTN)
U1111-1122-4477
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 268174 0
Metabolic syndrome 268175 0
Type 2 diabetes 268176 0
Cardiovascular condition 310651 0
Condition category
Condition code
Metabolic and Endocrine 268304 268304 0 0
Metabolic disorders
Diet and Nutrition 268352 268352 0 0
Obesity
Metabolic and Endocrine 268353 268353 0 0
Diabetes
Cardiovascular 309364 309364 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two groups of participants: energy restriction alone (ER) or energy restriction plus exercise intervention groups (EXER). EXER will follow the same energy restricted standard care clinical approach as ER. The exercise intervention will consist of a 12 month exercise program of small group and individual physical activity sessions (all supervised) and also home-based physical activity. The supervised exercise training will consist of the following:
3 x 1 hour supervised exercise sessions per week (weeks 1-6)
2 x 1 hour supervised exercise session per week (weeks 7-12)
1 x 1 hour supervised exercise session per week (weeks 13-26)
2 x 1 hour supervised exercise sessions per month (weeks 27-52)

The exercise training will consist of both moderate intensity aerobic and strength training using a variety of machines and free weights. Home-based physical activity will be developed around each participant’s access to equipment and facilities. It will predominantly include aerobic based exercise early in the program. Later in the program during the period of infrequent supervised sessions the home based program will be aerobic and resistance exercise as most suited to each participant. It is expected that the participants continue to progress the volume of the home based program during the 12 month intervention. Progression will lead to a minimum target of 200 minutes per week (including supervised sessions). Daily exercise will be encouraged.
Intervention code [1] 266836 0
Lifestyle
Comparator / control treatment
The control group ER will follow current usual care provided consisting of an individualised energy restricted diet based on the Optifast clinical protocol over 12 months. Regular consultations as part of standard care include nutritional assistance, counselling as required and encouragement to engage in physical activity.
Control group
Active

Outcomes
Primary outcome [1] 269045 0
Peak aerobic power (VO2 peak) as measured using a graded exercise test on a motorised treadmill.
Timepoint [1] 269045 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Primary outcome [2] 269047 0
Strength using the 3 repetition maximum (3RM) protocol
Timepoint [2] 269047 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [1] 276862 0
DEXA derived body composition
Timepoint [1] 276862 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [2] 276863 0
Physical activity and exercise was recorded using 7 day recall.
Timepoint [2] 276863 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [3] 276864 0
Quality of life using MOT SF-36 quality of life questionnnaire.
Timepoint [3] 276864 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [4] 276865 0
Musculoskeletal pain using 9 site visual analogue scale.
Timepoint [4] 276865 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [5] 276866 0
24 hour ambulatory blood pressure.
Timepoint [5] 276866 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [6] 276867 0
Depression and anxiety measured by:
Mini international neuropsychiatric interview,
Beck Depression Inventory II & Beck Depression Inventory Fast Screen,
Spielberger's State and Trait Anxiety Inventory
Timepoint [6] 276867 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [7] 276868 0
Endothelial function measured using endopat device
Timepoint [7] 276868 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [8] 276869 0
Muscle sympathetic nerve activity through microneurography.
Timepoint [8] 276869 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [9] 276870 0
Oral glucose tolerance test.
Timepoint [9] 276870 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [10] 276871 0
Bone formation and resorption measured through changes in osteocalcin, undercarboxylated osteocalcin, Procollagen I C-terminal propeptide, and C-telopeptide of type I collagen.
Timepoint [10] 276871 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [11] 276872 0
Changes to proinflammatory markers such as Interleukin-6, tumour necrosis factor-alpha, adiponectin, leptin through serum assays.
Timepoint [11] 276872 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [12] 276874 0
Changes in blood lipid profile through fasting blood sample.
Timepoint [12] 276874 0
Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
Secondary outcome [13] 354605 0
Sit to stands in 30 seconds
Timepoint [13] 354605 0
baseline, 3, 6, 12 months

Eligibility
Key inclusion criteria
Females aged 18-50 years.
Premenopausal
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes,
unstable cardiac condition,
Significant musculoskeletal complaint that prevents participation in any exercise,
Pregnant or planning pregnancy in the 12 months following surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women who express an interest in participating in the study must be deemed suitable by their GP and provide a formal medical clearance. The individual must also meet the
inclusion and exclusion criteria determined by the study protocol. The potential participant will then be contacted by the research team to discuss the project and provided with a detailed participant information and consent form. Once consented baseline testing is completed prior to surgery. Randomisation is conducted after successful surgery is confirmed. Allocation will be made by an independent researcher external to the study using sealed opaque envelopes for concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified balanced randomisation using PETO method (Peto, R., et al., Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Introduction and design. Br J Cancer, 1976. 34(6): p. 585-612)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
23/03/2012
Date of last participant enrolment
Anticipated
Actual
30/10/2015
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
60
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267310 0
University
Name [1] 267310 0
Deakin University
Country [1] 267310 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
Country
Australia
Secondary sponsor category [1] 266374 0
None
Name [1] 266374 0
Address [1] 266374 0
Country [1] 266374 0
Other collaborator category [1] 252075 0
Hospital
Name [1] 252075 0
Baker IDI Heart and Diabetes Institute
Address [1] 252075 0
Baker IDI Heart and Diabetes Institute (BIHDI)
PO Box 6492,
St Kilda Road Central, VIC, 8008
Country [1] 252075 0
Australia
Other collaborator category [2] 252086 0
Commercial sector/Industry
Name [2] 252086 0
LapSurgery Australia
Address [2] 252086 0
Langwith Consulting Suites
2 Langwith Avenue
BORONIA VIC 3155
Country [2] 252086 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269301 0
Deakin University Human Research Ethics Committee (EC00213)
Ethics committee address [1] 269301 0
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
Ethics committee country [1] 269301 0
Australia
Date submitted for ethics approval [1] 269301 0
05/07/2011
Approval date [1] 269301 0
29/07/2011
Ethics approval number [1] 269301 0
2011-154
Ethics committee name [2] 269302 0
Alfred Hospital Ethics Committee (EC00315)
Ethics committee address [2] 269302 0
Alfred Hospital
6A Commercial Rd,
Prahran, VIC, 3181
Ethics committee country [2] 269302 0
Australia
Date submitted for ethics approval [2] 269302 0
05/08/2011
Approval date [2] 269302 0
21/10/2011
Ethics approval number [2] 269302 0
330/11

Summary
Brief summary
The study aims to determine if exercise during significant weight loss as a result of a very low calorie diet influences cardio-metabolic risk factors to a greater extent than current standard practice and in doing so enhances patient adherence to a healthier lifestyle.
Design and Methods
120 pre menopausal females, aged 18 and 50 years will be recruited for this study. Participants will be randomly allocated into either a 12 month exercise intervention (EXER) group or control (standard care ER) group. People will be excluded from the study if they have: (i) muscle or joint problems that limit physical activity, (ii) have type 1 diabetes, (iii) are pregnant or planning to become pregnant in the next 12 months, or are breast feeding, (iv) Unstable cardiac condition.

The exercise group will train with an accredited exercise physiologist (AEP) and/or Masters of clinical exercise physiology student three days per week for 6 weeks and slowly reduce in face to face contact over the 12-month period. During the 12-month period participants will increase home based exercise developed in conjunction with the AEP and/or Masters student. The AEP will remain in regular contact with the participants through the use of telecommunication, email and social networking in addition to the supervised training that progressively reduces to fortnightly consultations in the second 6 month period. The intention of this model is to help the participant move from high reliance and contact with the AEP to self-management of their own exercise program, while still receiving ongoing support of the AEP. Training will consist of a variety of aerobic and resistance exercise with a 5 minute warm up followed by 50 minutes of exercise and 5 minutes of cool down at either: Deakin University Burwood campus, BakerIDI, or community based facility.

At baseline and at 3, 6 and 12 months, after recruitment participants will undergo the following assessments at Deakin University Burwood and Baker IDI:
Dual-energy X-ray absorptiometry (DXA) body composition; fasting blood collection to measure cholesterol, glucose, insulin, markers of bone formation and breakdown; muscle strength tests, aerobic capacity (fitness) test; sit to stand out of a chair, blood pressure over 24 hours, physical activity recordings using an accelerometor, recordings of nerve activity of the leg and testing of the elasticity of the blood vessels using non-invasive methods; and questionnaires to assess quality of life, exercise self efficacy, and rating of musculoskeletal pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32798 0
Prof Steve Selig
Address 32798 0
Deakin University
School of Exercise and Nutrition Science
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 32798 0
Australia
Phone 32798 0
+613 92446605
Fax 32798 0
Email 32798 0
[email protected]
Contact person for public queries
Name 16045 0
Prof. Steve Selig
Address 16045 0
School of Exercise & Nutrition Sciences
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
Country 16045 0
Australia
Phone 16045 0
(int + 61) 418570772
Fax 16045 0
(int + 61 3) 9244 5551
Email 16045 0
[email protected]
Contact person for scientific queries
Name 6973 0
Prof. Steve Selig
Address 6973 0
School of Exercise & Nutrition Sciences
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
Country 6973 0
Australia
Phone 6973 0
(int + 61) 418570772
Fax 6973 0
(int + 61 3) 9244 5551
Email 6973 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The authors have decided not to share individual participant data as this level of dissemination has not been approved by ethics. The participants have also not provided consent for this to occur.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
292Study protocol    https://trialsjournal.biomedcentral.com/articles/1... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: Study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1232-5
EmbaseFitness, Strength and Body Composition during Weight Loss in Women with Clinically Severe Obesity: A Randomised Clinical Trial.2020https://dx.doi.org/10.1159/000506643
N.B. These documents automatically identified may not have been verified by the study sponsor.